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`Andrew J. Miller
`Stuart D. Sender
`Alan H. Pollack
`Dmitry Shelhoff
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078
`Tel: (973) 379-4800
`
`Attorneys for Defendants
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
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`
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`Defendants
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`ANSWER OF DR. REDDY’S LABORATORIES, LTD.
`AND DR. REDDY’S LABORATORIES, INC.
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`Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
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`(collectively “DRL”) by their attorneys, for their answer to the Complaint by AstraZeneca AB,
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`AstraZeneca LP, and Pozen Inc., (collectively, “AstraZeneca” or “Plaintiffs”) respond to
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`allegations as follows:
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`00917971
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`Civil Action No. 3:13-cv-00091 (JAP)(TJB)
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`ELECTRONICALLY FILED
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`ASTRAZENECA AB, ASTRAZENECA LP,
`and POZEN INC.,
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`
`Plaintiffs,
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`v.
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`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 2 of 12 PageID: 98
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`Nature of the Action
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`1.
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`DRL admits the allegations contained in paragraph 1 of the Complaint.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`10.
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`The Parties
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`DRL admits the allegations contained in paragraph 2 of the Complaint.
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`DRL admits the allegations contained in paragraph 3 of the Complaint.
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`DRL admits the allegations contained in paragraph 4 of the Complaint.
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`DRL admits the allegations contained in paragraph 5 of the Complaint.
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`DRL admits the allegations contained in paragraph 6 of the Complaint.
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`DRL admits the allegations contained in paragraph 7 of the Complaint.
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`DRL admits the allegations contained in paragraph 8 of the Complaint.
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`BACKGROUND
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`The NDA
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`DRL admits the allegations contained in paragraph 9 of the Complaint.
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`DRL admits the allegations contained in paragraph 10 of the Complaint.
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`The Patent in Suit
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`11.
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`DRL denies the allegations of paragraph 11 of the Complaint, except admits that
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`the U.S. Patent No. 6,926,907 (“the ‘907 patent”), entitled “Pharmaceutical Compositions for the
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`Coordinated Delivery of NSAIDs,” issued on August 9, 2005, and that the Complaint annexes a
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`copy of the ‘907 patent as Exhibit A.
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`12.
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`DRL lacks information or knowledge sufficient to admit or deny the allegations
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`set forth in paragraph 12 of the Complaint, except that DRL admits that the ‘907 patent states on
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`its face that the assignee of the patent is Pozen Inc.
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 3 of 12 PageID: 99
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`13.
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`DRL denies the allegations of paragraph 13 of the Complaint, except admits that
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`the U.S. Patent No. 5,714,504 (“the ‘504 patent”), entitled “Compositions,” issued on February
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`3, 1998, and that the Complaint annexes a copy of the ‘504 patent as Exhibit B.
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`14.
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`DRL lacks information or knowledge sufficient to admit or deny the allegations
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`set forth in paragraph 14 of the Complaint, except that DRL admits that the ‘504 patent states on
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`its face that the assignee of the patent is Astra Aktiebolag.
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`15.
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`DRL denies the allegations of paragraph 15 of the Complaint, except admits that
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`the U.S. Patent No. 7,745,466 (“the ‘466 patent”), entitled “Form of S-omeprazole,” issued on
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`June 29, 2010, and that the Complaint annexes a copy of the ‘466 patent as Exhibit C.
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`16.
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`DRL lacks information or knowledge sufficient to admit or deny the allegations
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`set forth in paragraph 16 of the Complaint, except that DRL admits that the ‘466 patent states on
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`its face that the assignee of the patent is AstraZeneca AB.
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`17.
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`DRL denies the allegations of paragraph 17 of the Complaint, except admits that
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`the U.S. Patent No. 7,411,070 (“the ‘070 patent”), entitled “Form of S-omeprazole,” issued on
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`August 12, 2008, and that the Complaint annexes a copy of the ‘070 patent as Exhibit D.
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`18.
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`DRL lacks information or knowledge sufficient to admit or deny the allegations
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`set forth in paragraph 18 of the Complaint, except that DRL admits that the ‘070 patent states on
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`its face that the assignee of the patent is AstraZeneca AB.
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`19.
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`DRL denies the allegations of paragraph 19 of the Complaint, except admits that
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`the U.S. Patent No. 6,369,085 (“the ‘085 patent”), entitled “Form of S-omeprazole,” issued on
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`April 9, 2002, and that the Complaint annexes a copy of the ‘085 patent as Exhibit E.
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 4 of 12 PageID: 100
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`20.
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`DRL lacks information or knowledge sufficient to admit or deny the allegations
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`set forth in paragraph 20 of the Complaint, except that DRL admits that the ‘085 patent states on
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`its face that the assignee of the patent is AstraZeneca AB.
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`The ANDA
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`21.
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`22.
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`23.
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`24.
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`25.
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`DRL denies the allegations contained in paragraph 21 of the Complaint.
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`DRL admits the allegations contained in paragraph 22 of the Complaint.
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`JURISDICTION AND VENUE
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`DRL admits the allegations contained in paragraph 23 of the Complaint.
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`DRL admits the allegations contained in paragraph 24 of the Complaint.
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`DRL admits jurisdiction and venue in this case and denies the remaining
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`allegations in paragraph 25 of the Complaint.
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`26.
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`DRL admits jurisdiction and venue in this case and denies the remaining
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`allegations in paragraph 26 of the Complaint.
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`27.
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`DRL admits jurisdiction and venue in this case and denies the remaining
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`allegations in paragraph 27 of the Complaint.
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`28.
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`DRL admits jurisdiction and venue in this case and denies the remaining
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`allegations in paragraph 28 of the Complaint.
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`29.
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`30.
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`31.
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`32.
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`DRL admits the allegations contained in paragraph 29 of the Complaint.
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`DRL admits the allegations contained in paragraph 30 of the Complaint.
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`DRL admits the allegations contained in paragraph 31 of the Complaint.
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`DRL admits jurisdiction and venue in this case, with the balance being legal
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`points which require no response.
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 5 of 12 PageID: 101
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`33.
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`DRL admits jurisdiction and venue in this case and denies the remaining
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`allegations in paragraph 33 of the Complaint.
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`34.
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`35.
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`36.
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`37.
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`DRL admits the allegations in paragraph 34 of the Complaint.
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`DRL admits the allegations in paragraph 35 of the Complaint.
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`DRL admits the allegations in paragraph 36 of the Complaint.
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`DRL admits jurisdiction and venue in this case and denies the remaining
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`allegations in paragraph 37 of the Complaint.
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`38.
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`DRL admits the allegations in paragraph 38 of the Complaint.
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`COUNT I
`(INFRINGEMENT OF THE ‘907 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
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`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
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`39.
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`forth here.
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`40.
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`DRL denies the allegations of paragraph 40 of the Complaint, except admits that
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`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
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`41.
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`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
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`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 41 of the Complaint.
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`42.
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`43.
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`44.
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`45.
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`46.
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`DRL denies the allegations contained in paragraph 42 of the Complaint.
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`DRL denies the allegations contained in paragraph 43 of the Complaint.
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`DRL denies the allegations contained in paragraph 44 of the Complaint.
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`DRL denies the allegations contained in paragraph 45 of the Complaint.
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`DRL denies the allegations contained in paragraph 46 of the Complaint.
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`COUNT II
`(INFRINGEMENT OF THE ‘504 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
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`47.
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`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
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`forth here.
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`48.
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`DRL denies the allegations of paragraph 48 of the Complaint, except admits that
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`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
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`49.
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`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
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`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 49 of the Complaint.
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`50.
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`DRL denies the allegations contained in paragraph 50 of the Complaint, except
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`admits that its Notice of Paragraph IV Certification, dated November 20, 2012, does not allege
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`non-infringement of claims 1-3, 5-7, and 10 of the ‘504 patent, based on the information
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`available to DRL as of the time of the service.
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`51.
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`52.
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`53.
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`54.
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`55.
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`DRL denies the allegations contained in paragraph 51 of the Complaint.
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`DRL denies the allegations contained in paragraph 52 of the Complaint.
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`DRL denies the allegations contained in paragraph 53 of the Complaint.
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`DRL denies the allegations contained in paragraph 54 of the Complaint.
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`DRL denies the allegations contained in paragraph 55 of the Complaint.
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`COUNT III
`(INFRINGEMENT OF THE ‘466 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
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`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
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`56.
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`forth here.
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`57.
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`58.
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`59.
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`00917971
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`DRL denies the allegations contained in paragraph 57 of the Complaint.
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`DRL denies the allegations contained in paragraph 58 of the Complaint.
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`DRL denies the allegations contained in paragraph 59 of the Complaint.
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`6
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 7 of 12 PageID: 103
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`60.
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`61.
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`DRL denies the allegations contained in paragraph 60 of the Complaint.
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`DRL denies the allegations contained in paragraph 61 of the Complaint.
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`COUNT IV
`(INFRINGEMENT OF THE ‘070 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
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`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
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`62.
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`forth here.
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`63.
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`DRL denies the allegations of paragraph 63 of the Complaint, except admits that
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`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
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`64.
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`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
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`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 64 of the Complaint.
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`65.
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`DRL denies the allegations contained in paragraph 65 of the Complaint, except
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`admits that its Notice of Paragraph IV Certification, dated November 20, 2012, does not allege
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`invalidity of claims 2 and 4 of the ‘070 patent, based on the information available to DRL as of
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`the time of the service.
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`66.
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`67.
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`68.
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`69.
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`70.
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`DRL denies the allegations contained in paragraph 66 of the Complaint.
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`DRL denies the allegations contained in paragraph 67 of the Complaint.
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`DRL denies the allegations contained in paragraph 68 of the Complaint.
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`DRL denies the allegations contained in paragraph 69 of the Complaint.
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`DRL denies the allegations contained in paragraph 70 of the Complaint.
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`COUNT V
`(INFRINGEMENT OF THE ‘085 PATENT UNDER 35 U.S.C. § 271 (e)(2)(A))
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`DRL incorporates and repeats its responses to paragraphs 1-38 above as if set
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`71.
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`forth here.
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 8 of 12 PageID: 104
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`72.
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`DRL denies the allegations of paragraph 72 of the Complaint, except admits that
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`it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
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`73.
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`DRL admits that it was aware of the text of the 21 U.S.C. § 355(j)(2) and 21
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`C.F.R. § 314.95 (c) and denies the remaining allegations in paragraph 73 of the Complaint.
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`74.
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`75.
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`76.
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`77.
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`78.
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`79.
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`80.
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`DRL admits the allegations contained in paragraph 74 of the Complaint.
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`DRL denies the allegations contained in paragraph 75 of the Complaint.
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`DRL denies the allegations contained in paragraph 76 of the Complaint.
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`DRL denies the allegations contained in paragraph 77 of the Complaint.
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`DRL denies the allegations contained in paragraph 78 of the Complaint.
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`DRL denies the allegations contained in paragraph 79 of the Complaint.
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`DRL denies the allegations contained in paragraph 80 of the Complaint.
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`PRAYER FOR RELIEF
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`81.
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`DRL denies that Plaintiffs are entitled to judgments and relief prayed for in
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`paragraphs A through G of the Complaint.
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`AFFIRMATIVE DEFENSES
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`82.
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`DRL alleges and asserts the following affirmative defenses in response to the
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`allegations in AstraZeneca’s Complaint:
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`First Affirmative Defense
`(Non-infringement of Valid and Enforceable Claims)
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`The manufacture, use, offer for sale, sale or importation of the product described
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`83.
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`in DRL’s ANDA 204206 does not and will not infringe (either literally or under the doctrine of
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`equivalents), directly or indirectly (either by inducement or contributorily), any valid or
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`enforceable claim of the ‘907, ‘504, ‘466, ‘070 or ‘085 patents (collectively “patents-in- suit”).
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`Second Affirmative Defense
`(Invalidity)
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`At least claims 1, 5, 9-17, 21-24, 28-29, 32-35, 37, 41-42, 45-48, and 50-55 of the
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`84.
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`‘907 patent are invalid under Title 35 United States Code, including, inter alia, §§101, 102, 103,
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`112, and for double patenting.
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`85.
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`All claims of the ‘504 patent are invalid under Title 35 United States Code,
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`including, inter alia, §§101, 102, 103, 112, and for double patenting.
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`86.
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`All claims of the ‘466 patent are invalid under Title 35 United States Code,
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`including, inter alia, §§101, 102, 103, 112, and for double patenting.
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`87.
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`All claims of the ‘070 patent are invalid under Title 35 United States Code,
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`including, inter alia, §§101, 102, 103, 112, and for double patenting.
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`88.
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`All claims of the ‘085 patent are invalid under Title 35 United States Code,
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`including, inter alia, §§101, 102, 103, 112, and for double patenting.
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`Third Affirmative Defense
`(Non-Infringement)
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`The manufacture, use, sale, offer to sell in the United States or the importation
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`89.
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`into the United States of the product described in DRL’s ANDA 204206 does not and would not
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`infringe any of the claims of the ‘907 patent.
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`90.
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`The manufacture, use, sale, offer to sell in the United States or the importation
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`into the United States of the product described in DRL’s ANDA 204206 does not and would not
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`infringe at least claims 4, 8, and 9 of the ‘504 patent.
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`91.
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`The manufacture, use, sale, offer to sell in the United States or the importation
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`into the United States of the product described in DRL’s ANDA 204206 does not and would not
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`infringe any claim of the ‘466 patent.
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`92.
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`The manufacture, use, sale, offer to sell in the United States or the importation
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`into the United States of the product described in DRL’s ANDA 204206 does not and would not
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`infringe any claim of the ‘070 patent.
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`93.
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`The manufacture, use, sale, offer to sell in the United States or the importation
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`into the United States of the product described in DRL’s ANDA 204206 does not and would not
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`infringe any claim of the ‘085 patent.
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`Fourth Affirmative Defense
`(Prosecution History Estoppel)
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`94.
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`Claims of the patents in suit are so limited as not to cover the manufacture, use,
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`offer for sale, sale or importation of the product described in DRL’s ANDA 204206 due to the
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`arguments, statements, representations and/or amendments made by Plaintiffs to the United
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`States Patent and Trademark Office during the prosecution of the respective applications leading
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`to issuance of each of the patents in suit.
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`Fifth Affirmative Defense
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`95.
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`Each of Plaintiffs’ allegations of infringement of each of the patents in suit under
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`271(a), (b), and/or (c) fails to state a claim upon which relief can be granted.
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`WHEREFORE, DRL prays for relief as follows:
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`PRAYER FOR RELIEF
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`(a)
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`(b)
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`That the Complaint against DRL be dismissed in its entirety and with prejudice;
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`That the Court permanently enjoin Plaintiffs from asserting any one or more of
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`the ‘907, ‘504, ‘466, ‘070 and/or ‘085 patents against DRL or the purchasers of its Proposed
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`Product;
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`(c)
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`That this case be deemed to be an exceptional case within the meaning of 35
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`U.S.C. § 285;
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 11 of 12 PageID: 107
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`That DDRL be awaarded its attorney fees annd costs and
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`(dd)
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`(ee)
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`That tthe Court awward other annd further rellief as it deeems just and
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`expenses of f the suit, andd;
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`proper.
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`_____________________
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`
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`Andrew
`J. Miller
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`Stuart DD. Sender
`Alan H.
`Pollack
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`Dmitry SShelhoff
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`BUDD LLARNER, PP.C.
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`150 Johnn F. Kennedyy Parkway
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`Short Hiills, New Jerrsey, 07078
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`Tel: (9733) 379-4800
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`Attorneyys for Defenddants
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`Dr. Redddy’s Laborattories, Inc.
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`Dr. Redddy’s Laborattories, Ltd. aand
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`By:
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`DDated: Januaary 11, 2013
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`00917971
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`Case 3:13-cv-00091-MLC-DEA Document 5 Filed 01/11/13 Page 12 of 12 PageID: 108
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`CCERTIFICAATE OF SEERVICE
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`Carissa LL. Rodrigue (crodrigue@@mccarter.coom)
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`Stepheen M. Hash
`(shash@vel
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`VINSOON & ELKIINS, LLP
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`2801 VVia Fortuna,, Suite 100
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`Austinn, Texas 787746-7568
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`aw.com)
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`hereby certiify that on JJanuary 11, 22013, I caussed a true annd correct coopy of Answwer of
`I
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`Dr. Redddy’s Laboratories, Ltdd. and Dr.
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`Reddy’s LLaboratories,
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`Inc.; Rulee 7.1 Discl
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`Statemennt; and Certiffication Purssuant to L. CCiv. R. 11.2 tto be servedd via e-mail aand ECF upoon:
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`John Flahherty (Jflaheerty@mccartter.com)
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`Jonathann Short (jshorrt@mccarterr.com)
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`MCCARRTER & ENGGLISH, LLPP
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`Four Gatteway Centerr
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`100 Mulbberry Street
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`Newark, New Jersey 07102
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`Einar Stoole (estole@cov.com)
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`COVINGGTON & BUURLING LLLP
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`1200 Pennnsylvania AAvenue
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`Washinggton, DC 200004-2401
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`
`om)
`renk@fchs.cHenryy J. Renk (hr
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`FITZPPATRICK CCELLA HARRPER &
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`SCINTTO
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`New YYork, NY 100104-3800
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`1290 AAvenue of thhe Americass
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`_____________ ______________________________________________
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`Dmitry Sheelhoff (dshelhhoff@buddllarner.com)
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`BUDD LARRNER, P.C.
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`150 John F.. Kennedy PParkway
`Short Hills,
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` New Jerseyy 07078
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`Telephone ((973) 379-48800
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`Dr. Reddy’ss Laboratoriies, Ltd. andd
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`Attorneys foor Defendannts
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`Dr. Reddy’ss Laboratoriies, Inc.
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`00917971
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